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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1: Difference between revisions

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== Document Information ==
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}


== Reference Details ==
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|-
! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| IVD
| IVD
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| Article 76
| Article 76
Paragraph 1
Paragraph 1
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
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|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
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|  
|-
|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
|  
|  
|-
|-
! scope="row" | Comment
! Comment
| Recording and reporting AEs in performance studies
| Recording and reporting AEs in performance studies
|}
|}


== Text ==
== Content ==
Recording and reporting of adverse events that occur during performance studies
Recording and reporting of adverse events that occur during performance studies


Revision as of 14:27, 29 June 2026



Document information
Reference EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
Validity area EU
Scope(s) IVD
Document name Regulation (EU) 2017/746 - in vitro diagnostic medical devices
Version / Revision 20-Mar-2023
Status Current
Document type Legal act
Language(s) EN
Description Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Scope IVD
Document part Article 76

Paragraph 1

Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Recording and reporting AEs in performance studies

Content

Recording and reporting of adverse events that occur during performance studies

1. The sponsor shall fully record all of the following:

(a) any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;

(b) any serious adverse event;

(c) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(d) any new findings in relation to any event referred to in points (a) to (c).

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